Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/08—Inhaling devices inserted into the nose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2041—Separating means having removable plugs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
  • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
  • A61M15/0031—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up by bursting or breaking the package, i.e. without cutting or piercing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
  • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
  • B65D1/09—Ampoules
  • B65D1/095—Ampoules made of flexible material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/06—Head
  • A61M2210/0618—Nose
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/52—Details

Definitions

• the present invention relates to a two-part plastic blank set, preferably for the manufacture of an active agent applicator for the maintenance of a unit dose of active substance blurring and for the administration of this unit dose into the human nose; and a drug applicator producible therefrom.
• active ingredient applicators are known, which are intended for single use and thereby exert a dual function: First, they contain a fixed predetermined dosage of drug preparation. On the other hand, they serve not only to provide, but also the supply of the drug preparation in the desired amount to the desired location. Such drug applicators, which may have a small volume on the order of one cubic centimeter or less, are generally in the form of a small bottle and are laterally compressed to dispense the contents of the container to squeeze out the container contents.
• Such an agent applicator for the delivery and administration of a unit dose into the nose is known from the Registered Community Design 001790908-0001 or DE 10 2010 033 015 Alb
• the said active agent applicator has a lower part and a lid part, between which a Aumahmeraum is formed for a drug formulation.
• the lower part and the cover part each have a peripheral sealing edge for sealing connection of the cover part with the lower part.
• the lower part is provided with an application tube, which opens into the receiving space by means of an inner mouth.
• the application tube provided for insertion into the nose protrudes at a shallow angle from the receiving space over the seal edges and thereby covers a supporting-foil portion of the lower-part sealing edge.
• Lower part and lid part are integrally formed via a film hinge
• a one-piece plastic blank for forming such WirkstofTapplikators can be produced as an injection molded part cost under the conditions of mass production.
• the filling and closing of this plastic blank is difficult because of the geometrical arrangement of the application tube.
• For the filling a positionally accurate positioning of the still open blank is required, in which the application tube is in the way
• a back pressure must be applied to the sealing edge of the lower part, which extends over the entire sealing surface. This is the only way to ensure a hermetically sealed seal that works all around. In the area of the application tube but the sealing edge is covered by this, so that here access to the sealing edge for applying the back pressure is denied
• the active substance applicators known from the prior art only allow the delivery of very low viscosity active substance simulations, for example viscosities of not more than 1000 mPa ⁇ s. Also, in the prior art, a satisfactory dose constancy is not regularly achieved when, for example, daily monodose drug applicators are used, which should always administer a constant dose.
• a two-part plastic blank set preferably for producing a drug applicator for storing a unit dose of a drug formulation and for administering this unit dose into the human nose
• the plastic blank set comprises a lower part and a cover part separated from the lower part, wherein the lower part has a Aufiiahmeraumausforniung enclosed by a sealing edge and extending from the Aufiiahmeraumausformung a one-piece molded application tube, which closed at its free end with a one-piece integrally formed via a neck closure is, wherein the neck member has a wall thickness of 0.1-0.5 mm, preferably 0.2-0.3 mm, and wherein the lid part has a size to completely cover the Aufiiahmeraumausformung thereof when placed on the lower part, and a Sealing edge, which is sealingly connectable to the sealing edge of the lower part, wherein at least on the cover part or on the lower part is formed from the respective sealing edge, preferably in the same plane of the sealing edge
• the attachment tab extending from a seal edge or both seal edges is particularly useful when product information is to be applied to the lid portion or base. This can be done, for example, by attaching a label to the attachment plate or by printing on the attachment plate. The use of a label prevents adhesive from getting into the hanger remold. If both the sealing edge of the lower part and the sealing edge of the upper part attached thereto and the finished Wirkstoffapplikator opposite approach platelets, these can also be sealed together, which further improves the tightness and stability of the manufactured drug applicator. It has also been found that the attachment plate can be used to particular advantage so that the lower part and / or the upper part can be used in a holding device of a filling and closing device or can.
• ultrasonic welding results can be designed process-reliable.
• Grooves as energy directors are known in the field of ultrasonic welding and in particular have the task to initiate the plasticization of the joining surfaces by energy concentration quickly.
• an energy directing device When using an energy directing device, a seam formation occurs at the weld, which improves the strength and uniformity of the welding result.
• at least one sealing edge is provided on the opposite surface of the other sealing edge with small grooves.
• the Aufhahmeraumausformung kugelkappenftSrmig or spherical section is The Aurhahmeraumausformung can also, for example, have an oval floor plan, the peripheral sealing edge and the sealing edge of the lid part are then also suitably oval-shaped.
• cover part is substantially flat
• plastic blank set is made of polyolefin, for example polypropylene or polyethylene
• the polyolefin contains an inorganic additive.
• the inorganic additive is a pigment, preferably titania (TiO 2 ) surface treated titanium dioxide or a mixture thereof
• the additive is present in the Kunststoffstorrmaterial in an amount between 0.1 and 10 wt .-%.
• the plastic material may preferably be processed via extrusion injection molding.
• an active substance applicator which can be produced by welding, preferably ultrasonic welding, the lower part with the cover part of the two-part plastic blank set according to one of claims 1 to 7 over the respective sealing edges and is filled with an active ingredient formulation, wherein the active ingredient formulation preferably has a viscosity of over 2,500 mPa ⁇ s, preferably over 3,000 mPa ⁇ s, more preferably having a viscosity in a range of 3,000-8,000 mPa ⁇ s, as measured with a Brookfield viscometer HBDV-3, spindle CP41, at a temperature of 20 ° C ,
• the Brookfield HBDV-3 device includes a cone-plate system.
• the viscosity of the active ingredient formulation is determined according to European Pharmacopoeia 9.1, chapter 2.2.10.
• the drug delivery applicator is for use in administering the drug formulation contained in the drug applicator into the nose of a mammal, preferably a human.
• the administration is for the therapeutic or prophylactic treatment of the mammal
• a further embodiment is characterized in that the active substance formulation after application from the active substance applicator forms a protective film against harmful substances in the nose, preferably against nanoparticles present in the atmosphere.
• active substance formulations may also be administered via the active substance applicator according to the invention, in particular if they have a higher viscosity.
• the distribution of centrally active molecules in favor of the central nervous system can be optimized with the active substance applicator according to the invention. Furthermore, the modification of the release of the active ingredient is possible.
• the lower part, the cover part and the Applikaüonsrschreibe a wall thickness of at least 0.1 mm, preferably 0.2 mm, more preferably from 0.2 to 2.0 mm, more preferably from 0.2 to 1, 5 mm or more preferably 0.2-1.0 mm.
• the application tube integrally formed on the Aufhahmeraurnausformung is open to Aufhahmeraumausformung.
• the free end of the application tube is closed by a closure, preferably a tearable stopper or pin.
• the closure is connected to the application tube via an attachment element, preferably a tear-off seam.
• the closure e.g. by turning about its longitudinal axis, away from the applicator tube.
• the necking element is located inside the application tube so that in use no residual burr protrudes from the application tube so that it can not cause injury, such as into the nose of a user is introduced.
• the active substance applicator produced according to the invention is characterized in particular by a receiving space formed by the cover part and the lower part, which has an outwardly curved wall and an opposite wall, which has a peripheral web is provided, which engages in the cavity of the curved wall at its edge, wherein the curved wall is shaped so that it is smoothly pressed against the web and the intermediate region of the opposite wall.
• the curved wall substantially without remaining space on the web and the opposite wall, so that practically the entire contents of the Aumahmeraum is pushed out without a significant residual amount can remain, as the curved wall smooth, without Forming wrinkles around the bridge against the opposite wall
• the bridge which preferably has a generally conical shape in cross-section, with a rounded tip and slightly rounded flanks, fills in the space that inevitably forms when compressing a curved wall at its outer edge Since this space is filled by the bridge, there can be no residual amount of container contents left there.
• polyolefins such as polypropylene, polyethylene or copolymers of ethylene and propylene, suitable, without the invention being limited
• the fiction, contemporary drug applicator allows for the first time the application of a drug formulation with higher viscosity, ie over 3,500 mPa ⁇ s, in the nose of a Mammal.
• the Wirkstofiiapplikator invention also allows a dosage constancy of about ⁇ 3% when filled with identical drug formulation drug applicators are used sequentially over a longer period of time as monodose applicators.
• FIG. 1 is a perspective view of a two-part plastic blank set of lower part and upper part according to the invention.
• FIG. 2 shows a perspective view of an active substance applicator according to the invention made from the lid part and the lower part.
• the plastic blank set comprises a lower part 2 and a cover part 3.
• the lower part 2 has an enclosed by a sealing edge 5 Aufhahmeraumausformung 12, which is formed substantially spherical cap-shaped starting from the receiving space 12 extends an integrally molded application tube 7, at its free End is closed with a likewise integrally formed via a projection element 15 closure 14.
• the lid part 3 has a size to completely cover the receiving space formation 12 of the lower part 2 can.
• the cover part 3 further has a peripheral sealing edge 6, which is sealingly connectable to the sealing edge 5 of the lower part 2.
• the cover part 3 is substantially planar and has a sealing edge 6 with grooves 17 as energy directors.
• Both the lower part 2 and the lid part 3 have lug plates 16 which extend from the respective sealing edge in the same plane. These attachment plates can be printed on their sides facing away from the other part or provided with an adhesive label.
• the lower part can be placed in a filling and Verschweeinrichrung, as it is known for example from EP 2 626 304 Bl.
• the lower part 2 is first inserted and filled and placed after filling of the lower part 2, the cover part 3 on the lower part 2, that its sealing edge 6 on the receiving space around the 12th.
• the presence of an attachment plate on the lower part or upper part ensures the secure insertion into a holder of the filling and closing device.
• the welding preferably ultrasonic welding, then takes place according to routine methods known in the art.
• FIG. 2 An active substance applicator 1 produced in this way is shown in FIG. 2.
• the lower part 2 and the upper part 3 together form a receiving space 4 in which an active ingredient formulation is received.
• the closure 14 is first broken off or turned off via the attachment element 15 and then the application tube 7 is inserted into a nostril, whereby the active ingredient formulation stored in the receiving space 4 by the application tube 7 is then pressed or thumb-pressed onto the Aurhahrneraumausformung 12 is pressed in the nose.
• the attachment element 15 has a wall thickness in the range of 0.1-0.5 mm, preferably 0.2-0.3 mm.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pulmonology (AREA)
• Pharmacology & Pharmacy (AREA)
• Otolaryngology (AREA)
• Mechanical Engineering (AREA)
• Fluid Mechanics (AREA)
• Ceramic Engineering (AREA)
• Physics & Mathematics (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Closures For Containers (AREA)
• Coating Apparatus (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
• Materials For Medical Uses (AREA)
• Cartons (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Priority Applications (10)

Applications Claiming Priority (2)

Publications (1)

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Citations (5)

Family Cites Families (33)

• 2016
  • 2016-05-25 ES ES16171312T patent/ES2870984T3/es active Active
  • 2016-05-25 DK DK16171312.8T patent/DK3248646T3/da active
  • 2016-05-25 HU HUE16171312A patent/HUE054071T2/hu unknown
  • 2016-05-25 EP EP16171312.8A patent/EP3248646B1/de active Active
  • 2016-05-25 PL PL16171312T patent/PL3248646T3/pl unknown
  • 2016-05-25 PT PT161713128T patent/PT3248646T/pt unknown
  • 2016-05-25 SI SI201631102T patent/SI3248646T1/sl unknown
• 2017
  • 2017-03-30 MX MX2018014313A patent/MX2018014313A/es unknown
  • 2017-03-30 EP EP17713687.6A patent/EP3463545A1/de not_active Withdrawn
  • 2017-03-30 US US16/092,043 patent/US20190117917A1/en not_active Abandoned
  • 2017-03-30 JP JP2018560077A patent/JP2019518517A/ja active Pending
  • 2017-03-30 BR BR112018071328A patent/BR112018071328A2/pt not_active Application Discontinuation
  • 2017-03-30 CA CA3018928A patent/CA3018928C/en active Active
  • 2017-03-30 WO PCT/EP2017/057515 patent/WO2017202529A1/de unknown
  • 2017-03-30 CN CN201780032109.5A patent/CN109310852A/zh active Pending
  • 2017-03-30 KR KR1020187036047A patent/KR20190013829A/ko not_active Application Discontinuation
  • 2017-03-30 AU AU2017271199A patent/AU2017271199B2/en active Active
• 2018
  • 2018-10-03 ZA ZA2018/06574A patent/ZA201806574B/en unknown
• 2021
  • 2021-04-26 HR HRP20210653TT patent/HRP20210653T1/hr unknown

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